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Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

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ClinicalTrials.gov Identifier: NCT03228485
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Société Internationale d'Urologie

Brief Summary:
This study assesses the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve for treatment. Patients will be enrolled in the study by their physician (GP or urologist). The patients will receive a daily medication reminder including frequent feedback on medication adherence. Furthermore, standard questionnaires will be filled out via the application. The hypothesis of this pilot study is that application is feasible and accepted in this group of patients.

Condition or disease Intervention/treatment
Prostatic Hyperplasia Lower Urinary Tract Symptoms Device: MyBPH Care mobile app

Detailed Description:

Rationale:

One of the next developments in healthcare is digitalization, including (mobile) applications that could support healthcare providers. A significant number of aging men suffer from lower urinary tract symptoms (LUTS), often caused by benign prostate hyperplasia (BPH). LUTS/BPH is primarily treated by physicians (GPs or Urologists). Optimal evaluation of patients with LUTS/BPH, treatment selection and follow-up by the physicians and medication adherence are essential in the management of LUTS. This pilot project represents a strong collaboration between a urological association, urologists, and physicians in supporting healthcare improvement for LUTS/BPH with the use of a (mobile) application. The hypothesis is that the (mobile) application can support the patient in medication adherence and improve the adherence by feedback and that the application can help to collect objective disease information with electronic questionnaires.

Objectives:

The primary objective is to assess the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve for treatment.

The secondary objectives are to identify potential gaps, clarify controversial points of the application, to document the communication between patients, physicians and supervising urologists in order to optimize (if necessary) the application, to assess medication adherence and to record if treatment provided by physicians is in compliance with the guidelines recommendations.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MyBPH Care
All patients enrolled in this study.
Device: MyBPH Care mobile app
The application that will give daily medication reminders and via which the questionnaires can be filled out.




Primary Outcome Measures :
  1. Feasibility of a mobile application for LUTS [ Time Frame: 6 months ]
    The feasibility is assessed by the application use of patients. The patients application will be judged as Definitely Feasible if the study is completed for ≥70% eligible patients, Possibly Feasible (completed for 50-69% eligible patients) or Not Feasible (completed for <50%).


Secondary Outcome Measures :
  1. Acceptability and satisfaction of a mobile application for LUTS [ Time Frame: 6 months ]
    In order to assess the acceptance and satisfaction of the mobile application including the application subjective quality and perceived impact, a questionnaire will be used. This questionnaire is based on a standardized application rating questionnaire, namely the user Mobile Application Rating Scale (uMARS). Outcomes are described and compared between centers.

  2. Medication adherence [ Time Frame: 6 months ]
    Self-reported medication adherence by the patient via the application over the full period of the pilot.

  3. Compliance to guidelines [ Time Frame: At baseline ]
    Descriptive comparison between the medication prescribed by the physician and the advised medication according to the international guidelines based on the patient characteristics.

  4. Referral network [ Time Frame: At the end of the 6 months period ]
    Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population will be men, age ≥ 40, presenting at their physician's office with LUTS/BPH symptoms and a clear history for LUTS/BPH medication.

The study will be conducted by five centers in five countries, Institute for Monitoring of Urogenital Diseases in Larissa, Greece, the Istanbul Medipol University in Turkey, the Hospital Universitario la Zarzuela in Spain, the Hospital de San António in Portugal, and the University of Florence in Italy. The participating physicians will be from these areas and thus so will the participants.

Criteria

Inclusion Criteria:

  • Male
  • Age ≥ 40
  • Bothersome LUTS
  • Start of medical therapy for LUTS
  • No previous LUTS/BPH treatment (medical or invasive)
  • In possession of a smartphone, tablet or computer with internet connection
  • Access to email
  • Fluent speaking and reading of the national language
  • Signed informed consent

Exclusion Criteria:

  • Previous LUTS/BPH treatment with medication or surgery
  • Previous pelvic surgery or radiotherapy
  • History of neurological disease
  • History of bladder or prostate cancer
  • Unable to provide informed consent
  • Analphabet
  • Unable to operate a smartphone/ tablet/computer
  • Incapable of understanding the language in which the information for the patient is given

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228485


Contacts
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Contact: Stavros Gravas, MD +30-2413 502983 sgravas2002@yahoo.com
Contact: Jean de la Rosette, MD, PhD j.j.delarosette@gmail.com

Locations
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Greece
University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases Recruiting
Larissa, Greece, 10
Contact: S Gravas, Dr.    +30-2413 502983    sgravas2002@yahoo.com   
Italy
University of Florence Recruiting
Florence, Italy
Contact: Mauro Gacci, MD       maurogacci@yahoo.it   
Portugal
Hospital de Santo Antonio Recruiting
Porto, Portugal
Contact: Vitor Cavadas, MD       vcavadas@gmail.com   
Spain
Hospital Universitario la Zarzuela Not yet recruiting
Madrid, Spain, 28023
Contact: Ignacio Moncada Iribarren, Prof. Dr.       ignacio@moncada.name   
Turkey
Istanbul Medipol University Recruiting
Istanbul, Turkey
Contact: Jean J de la Rosette, Prof. dr.       j.j.delarosette@gmail.com   
Contact: Selçuk Guven, MD       selcukguven@hotmail.com   
Sponsors and Collaborators
Société Internationale d'Urologie
Investigators
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Study Chair: Stavros Gravas, MD Societe Internationale d'Urologie

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Responsible Party: Société Internationale d'Urologie
ClinicalTrials.gov Identifier: NCT03228485     History of Changes
Other Study ID Numbers: uCARE-2018-002
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Société Internationale d'Urologie:
Smartphone
Application
Pilot
mhealth

Additional relevant MeSH terms:
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Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms